Rivastigmine in the Management of Delirium

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.

Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Novartis Pharmaceuticals
• Treatments: Cholinesterase Inhibitors; Rivastigmine

Criteria

Inclusion Criteria:

• Patients aged 75 and over

• Hospitalization for delirium not correlated to surgery for less than 48 hours

• Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of consciousness) of the Confusion Assessment Model and DRS R-98 > 10

• Absence of any contraindications to a cholinesterase inhibitor treatment

• Health insurance affiliation

• Having signed an informed consent form

• Caregiver/informant to provide information on patient

Exclusion Criteria:

• Use of IAchE or memantine medication

• Contraindication to IAchE medication

• Frontotemporal dementia

• Diseases involving the short-term survival

• Digestive bleeding

• Ischemic and hemorrhagic stroke related to actual onset (including hemorrhagic contusion)

• Natremia ≤120 mmol/l at the time of hospitalization

• Post epileptic confusion

• Hepato-cellular failure

• Cardiorespiratory impairment at risk of transfer to intensive care unit

• Major sensory deficits that could interfere with cognitive assessment (visual and auditory)

• Not fluent in French

• Being under guardianship

• Absence of caregiver/informant to sign informed consent form